About this trial
This pilot randomized controlled trial will examine the feasibility, acceptability and preliminary efficacy of an adolescent depression prevention program, Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST), in primary care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adolescents ages 13 to 17 years.
Adolescents must be English-speaking.
Legal guardian permission (informed consent) and child consent/assent.
A score of 5-10 on the Patient Health Questionnaire 9-Item: Modified for Teens (PHQ-9-M) at the primary care well-visit.
Disqualifiers
Suicidal ideation or behaviors reported on the PHQ-9-M at their well-visit (score of 1 or higher on item 9 "In the past week, have you had thoughts that you would be better off dead, or of hurting yourself in some way?" and/or yes to either of the supplemental questions which ask, "Has there been a time in the past month when you have had serious thoughts about ending your life?" and "Have you ever, in your whole life, tried to kill yourself or made a suicide attempt?") based on medical record review. For the PHQ-9-M administered at baseline, adolescents who mark yes to the supplemental item about serious suicidal ideation in the past month ("Has there been a time in the past month when you have had serious thoughts about ending your life?") will be excluded.
Major medical illness, significant behavioral problems or intellectual or developmental disabilities that may interfere with the completion of all study procedures.
Youth may be excluded on a case-by-case basis if the EHR review, eligibility screener, baseline evaluation, or other interactions with the family suggests that the group program would not be appropriate.
Trial design
Parallel
Treatments tested in this trial
Brief Interpersonal Psychotherapy - Adolescent Skills Training (B-IPT-AST)
BehavioralThis is an adolescent depression prevention program consisting of 6 sessions (4 group and 2 individual sessions).
Services as usual (SAU)
BehavioralServices as usual (SAU) involves any mental health services adolescents decide to receive in primary care or in the community. It is possible that adolescents in SAU may decide not to participate in any mental health services.
Treatment groups
Trial outcomes
Primary outcomes
Acceptability: A self-report measure, the Attitude Towards Intervention Questionnaire (ATI)
A self-report measure, the Attitude Towards Intervention Questionnaire (ATI), will be completed by adolescents to assess acceptability of Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST) following the intervention. The ATI includes 11 Likert scale items and one open-ended item for providing additional feedback. Likert scales vary by item but are generally 3- or 5-point scales (e.g., very helpful to very unhelpful). Each item is interpreted on its own (e.g., the percentage of teens who found B-IPT-AST very or a little helpful)
Attendance
The number of individual and group B-IPT-AST sessions that teens attend will be tracked in order to report on the average number of group sessions attended (out of 4) for the total sample as well as the average number of individual sessions (out of 2) attended across the sample
Retention
To gauge feasibility, retention will be assessed by comparing the number of families who remain in the study through post-intervention to the number who consented.
Depression symptoms
Change in depression symptoms will be measured by the Center for Epidemiologic Studies-Depression Scale (CES-D) which assesses the frequency of 20 depressive symptoms over the past week; CES-D scores range from 0 to 60 (scores of 16 or higher are considered elevated); higher scores indicate more depression symptoms
Secondary outcomes
Internalizing and externalizing symptoms
Changes in internalizing and externalizing symptoms will be assessed by the Pediatric Symptom Checklist (PSC-17), which will be completed by teens and caregivers; there is a total score (range of 0-34), internalizing subscale (0-24), externalizing subscale (0-20), and attention problems subscale (0-24); higher scores indicate more symptoms
Impairment (Child Report)
Change in impairment will be measured via teen report on the Columbia Impairment Scale (CIS), 13-item scale of overall functioning; scores range from 0-52; a score of 15 or higher is considered elevated impairment; higher scores represent greater impairment
Impairment (Parent Report)
Change in impairment will be measured via parent report on the Columbia Impairment Scale (CIS), 13-item scale of overall functioning; scores range from 0-52; a score of 15 or higher is considered elevated impairment; higher scores represent greater impairment
Perspective-taking
Changes in perspective taking will be measured by the Interpersonal Reactivity Index (IRI), a 7-item perspective-taking scale; scores range from 0-28 with higher scores representing more perspective taking
Sponsors and contacts
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Children's Hospital of Philadelphia
Lead sponsor
The Klingenstein Third Generation Foundation
Collaborator